Disclaimer: This is for informational purposes only. This does not replace the instructions you received from Dr. Anderson or any other practitioner,
constitute medical treatment, establishment of a patient-physician relationship, constitute any form of recommendation, prescription or medical
advice, or imply that the medication is appropriate or FDA approved for any condition. This information may be outdated and is not a complete
listing of instructions, doses, uses, or side effects. If this was prescribed to you, you must review this information with your pharmacist and
prescriber before starting the medication. Any medication may interfere with the ability to drive, concentrate, or operate machinery; patients must
be responsible for their own behavior and should not engage in any dangerous activity if there is any question of impairment. All medications have
side effects and drug interactions, some serious, some fatal. Let all of your practitioners and pharmacist know about every substance used. Alcohol,
herbals, or illegal drugs are not considered safe with these medications. Assume no medication is safe during pregnancy or while breast feeding. The
medication may interfere with birth control. Almost any medication can cause sleepiness, insomnia, dizziness, confusion, hallucinations, anxiety,
panic, constipation or diarrhea, headache, chest pain and nausea or vomiting, among others. These could cause physical injury, such as dizziness
causing one to fall down stairs. Many reduce blood pressure, which could cause fainting, dizziness, stroke, or other problems. Most medications
should NOT be stopped suddenly because of the risk of withdrawal. This is a supplement to the standardized drug information sheets.
Drug: MODAFANIL and ARMODAFANIL
Wayne E. Anderson, D.O.
A Medical Corporation
Chronic Intractable Pain Disorders
Headache & Facial Pain Disorders
Neurotoxin Therapy
Board Certified Neurology
American Board of Psychiatry & Neurology
Board Certified Pain Medicine
American Board of Psychiatry & Neurology
in association with the
American Board of Anesthesiology
Subspecialty Certified Headache Medicine
United Council for Neurological
Subspecialties
Qualified Medical Evaluator
Member of the
California Pacific Neuroscience Institute
45 Castro Street Suite 225
San Francisco CA 94114
415.558.8584 tel
415.513.4521 fax
www.wayneanderson.net
FDA-approved uses: Modafinil (Provigil) and armodafinil
(Nuvigil) are wakefulness promoting medications. They are FDAapproved for excessive sleepiness associated with shift-work sleep
disorder, sleep apnea, and narcolepsy.
Common off-label uses: There are scientific data regarding fatigue
in chronic illness (such as MS or chronic pain). Such uses are offlabel but it is within the standard of care to use them for other
conditions with excessive sleepiness or fatigue, such as multiple
sclerosis, fibromyalgia, and other conditions.
Alternatives: Non-medication modalities, pain interventions and
other medications that may work in a similar manner.
How it works: They are not considered amphetamine stimulants. To
date, the exact way in which these medications work is not clearly
known, but there appears to be activity in the hypothalamus related
to H3 receptors. There also are data (see references below) suggesting
an effect at the locus ceruleus in the pons, with the result being
improved cognition (Minzenberg).
Side effects: Side effects include headache (especially for the first
few days) and nausea. Some patients had heart rhythm changes and
heart attacks; it is not clear whether the drug caused the problem or
if the patients would have had a heart attack anyway. If you have
heart problems, please discuss with the provider who cares for your
heart before using the medication. The most important issue is the
rare circumstance of a serious allergic-type rash. If any patient
develops anything even close to a rash, the prescribing provider
should be notified immediately and the drug should be stopped.
They should be used with caution if there are any liver problems.
There are interactions with other medications: Antifungals,
Phenobarbital, barbiturates, Tegretol, cyclosporins, linezolid, MAO
inhibitors, birth control pills, Dilantin, rifampin, tacrolimus,
theophyllines, Coumadin and other medications may interact. Oral
contraceptives may not work as well.
Common doses: Although these medications are similar, the tablet
sizes are different. Typical doses are one tablet in the morning (or the
equivalent of the morning for a shift-worker).
Time to effect: Within an hour or two.
Financial: Dr. Anderson has never received payment in exchange for prescribing a medication.
However, Dr. Anderson has served on advisory boards of pharmaceutical companies and has provided
medical education lectures paid by pharmaceutical companies. These types of activities are explained in
the financial disclosure. In the past, Dr. Anderson provided paid medical education lectures regarding
Provigil. Patients may request a medication made by a company for which Dr. Anderson has never
provided lectures, if desired.
Insurance coverage: Many medications, especially in painful conditions, are off-label as discussed
above. Insurance companies do not need to cover medications used off label but typically do provide
coverage for most medications that have good scientific evidence. There is no guarantee that any
medication will be covered. Armodafanil and modafanil are fairly costly medications even generically
and they are not typically covered by insurance plans. We cannot guarantee that we will be able to
obtain coverage for you.
Clinical and Scientific evidence: Some scientific evidence supportive of the use of the medication is
listed in this section. Of course, scientific information changes rapidly and the information listed may
become outdated or incorrect overnight. Modafinil and armodafinil for use for fatigue and tiredness in
various conditions. The literature provides early evidence for successful treatment of pain-associated
fatigue (2). There is also peer-reviewed evidence supportive of use for opioid-induced sedation in
chronic pain (1,3). These medications have FDA approval and therefore an evidence-base for shift-work
sleep disorder, an adjunct to sleep apnea, and narcolepsy. References:
1.
Reissig JE, Rybarczyk AM. Ann Pharmacother. 2005 Apr;39(4):727-31. Epub 2005 Mar 8. Pharmacologic treatment of opioidinduced sedation in chronic pain.
2.
Fishbain DA, Cutler RB, Lewis J, Cole B, Rosomoff HL, Steele-Rosomoff R. J Pain Palliat Care Pharmacother. 2004;18(2):39-47.
Modafinil for the treatment of pain-associated fatigue: review and case report.
3.
Webster L, Andrews M, Stoddard G. Pain Med. 2003 Jun;4(2):135-40. Modafinil treatment of opioid-induced sedation.
4.
Minzenberg MJ, Watrous AJ, Yoon JH, Ursu S, Carter CS. Modafinil shifts human locus coeruleus to low-tonic, high-phasic
activity during functional MRI. Science. 2008 Dec 12;322(5908):1700-2.